Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

Last updated: April 7, 2026
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Hidradenitis Suppurativa

Scalp Disorders

Treatment

Vehicle Cream

Ruxolitinib Cream

Clinical Study ID

NCT06958211
INCB018424-325
2024-517633-40-00
  • Ages > 12
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of HS for at least 6 months prior to screening visit.

  • Mild to moderate HS (Hurley I or II) with the following at both screening andbaseline visits:

  • A total AN count of at least 4, with no draining tunnels AND

  • Affecting at least 2 distinct anatomical areas

  • Agreement to NOT use topical and systemic antibiotics for treatment of HS during thevehicle-controlled period.

  • Agreement to NOT use topical antiseptics, including washes and leave-on products onthe areas affected by HS lesions during the vehicle-controlled period and Weeks 16to 20 of the extension period.

  • Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  • Body surface areas to be treated exceed 20% BSA at screening or baseline

  • Presence of draining tunnels at screening or baseline.

  • Medical history including current or history of certain infections, cancer,lymphoproliferative disorders and other medical conditions at the discretion of theinvestigator.

  • Laboratory values outside of the protocol-defined criteria.

  • Pregnant or lactating participants, or those considering pregnancy during the periodof their study participation.

  • Further exclusion criteria apply.

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Vehicle Cream
Phase: 3
Study Start date:
June 12, 2025
Estimated Completion Date:
July 11, 2027

Connect with a study center

  • Investigative Site BE204

    Brussels, 01070
    Belgium

    Active - Recruiting

  • Investigative Site BE204

    Brussels 2800866, 01070
    Belgium

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    Gent, 09000
    Belgium

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    Gent, 09000
    Belgium

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    Ghent, 09000
    Belgium

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    Ghent, 09000
    Belgium

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    Ghent 2797656, 09000
    Belgium

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  • Investigative Site BE203

    Ghent 2797656, 09000
    Belgium

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  • Investigative Site BE202

    Leuven, 03000
    Belgium

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  • Investigative Site BE202

    Leuven 2792482, 03000
    Belgium

    Site Not Available

  • Investigative Site BG201

    Sevlievo, 05400
    Bulgaria

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  • Investigative Site BG201

    Sevlievo 727337, 05400
    Bulgaria

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  • Investigative Site BG202

    Sofia, 01431
    Bulgaria

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  • Investigative Site BG203

    Sofia, 01592
    Bulgaria

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  • Investigative Site BG202

    Sofia 727011, 01431
    Bulgaria

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    Sofia 727011, 01592
    Bulgaria

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    Edmonton, Alberta T5K1X3
    Canada

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    Edmonton 5946768, Alberta 5883102 T5K1X3
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    Winnipeg, Manitoba R3M 3Z4
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    Winnipeg 6183235, Manitoba 6065171 R3M 3Z4
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    Fredericton, New Brunswick E3B 1G9
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    Fredericton 5957776, New Brunswick 6087430 E3B 1G9
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    Rouen Cedex, 76031
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    Saint Etienne Cedex 2, 42055
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    Saint-Etienne, 42055
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    Saint-Etienne 2980291, 42055
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    Toulouse, 31059
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    Toulouse 2972315, 31059
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    Toulouse Cedex 9, 31059
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    Bad Bentheim, 48455
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    Bad Bentheim 2953552, 48455
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    Hanover, 30159
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    Hanover 2910831, 30159
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    Kiel 2891122, 24105
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    Langenau, 89129
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    Langenau 2881259, 89129
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    Mainz, 55131
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    Merzig 2871675, 66663
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    Manises, 46940
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    Manises 2514197, 46940
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    Santiago de Compostela, 15706
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    Los Angeles, California 90056
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    New Orleans 4335045, Louisiana 4331987 70012
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    Active - Recruiting

  • Investigative Site US204

    Portland 5746545, Oregon 5744337 97201
    United States

    Site Not Available

  • Investigative Site US226

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Investigative Site US226

    Plymouth Meeting 5206666, Pennsylvania 6254927 19462
    United States

    Site Not Available

  • Investigative Site US256

    Bluffton, South Carolina 29910
    United States

    Active - Recruiting

  • Investigative Site US267

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Investigative Site US267

    Mt. Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Investigative Site US256

    Bluffton 4571722, South Carolina 4597040 29910
    United States

    Site Not Available

  • Investigative Site US267

    Mt. Pleasant 4588165, South Carolina 4597040 29464
    United States

    Site Not Available

  • Investigative Site US255

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Investigative Site US260

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • Investigative Site US270

    Prosper, Texas 75078
    United States

    Active - Recruiting

  • Investigative Site US232

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Investigative Site US255

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Investigative Site US260

    Cypress 4684724, Texas 4736286 77429
    United States

    Site Not Available

  • Investigative Site US270

    Prosper 4720833, Texas 4736286 75078
    United States

    Site Not Available

  • Investigative Site US232

    Sugar Land 4734825, Texas 4736286 77479
    United States

    Site Not Available

  • Investigative Site US248

    Arlington, Virginia 22206
    United States

    Active - Recruiting

  • Investigative Site US209

    Danville, Virginia 24541
    United States

    Active - Recruiting

  • Investigative Site US229

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Investigative Site US248

    Arlington 4744709, Virginia 6254928 22206
    United States

    Site Not Available

  • Investigative Site US209

    Danville 4755280, Virginia 6254928 24541
    United States

    Site Not Available

  • Investigative Site US229

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Investigative Site US265

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Investigative Site US224

    Spokane, Washington 99202
    United States

    Active - Recruiting

  • Investigative Site US265

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

  • Investigative Site US224

    Spokane 5811696, Washington 5815135 99202
    United States

    Site Not Available

  • Investigative Site US210

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Investigative Site US210

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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